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Electronic safety reporting

29/7/2010

Currently expedited reports from clinical trials, SUSARs, can still be submitted via CIOMS forms to the MHRA. However, after 1st September 2010 the MHRA will no longer accept such non-electronic reports.  From this date only electronic reports via the Eudravigilance gateway, via EVWEB or via the MHRAs new eSUSAR reporting facility will be accepted.

If you are not already registered, Wainwright Associates' pharmacovigilance consultants can assist you with the registration and testing process for electronic reporting.